BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVEIRSAL RECIPROCATING SAW ATTACHMENT

    MDR report key: 3113132 · Received May 9, 2013

    Report

    Report Number
    8031000-2013-00026
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    ZIMMER SURGICAL S.A.
    Product Code
    GFA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER, THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION TOTAL KNEE REPLACEMENT, THE UNIVERSAL RECIPROCATING SAW ATTACHMENT EASILY RELEASED THE BLADE, LEAVING IT IN THE SURGICAL SITE AFTER APPROXIMATELY 6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204977 UNIVEIRSAL RECIPROCATING SAW ATTACHMENT UNIVERSAL RECIPROCATINGS SAW ATTACHMENT GFA ZIMMER SURGICAL S.A. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)| SYNVASIVE DOUBLE SIDED RECIPROCATING BLADE